GAITHERSBURG, Md. - The government should remove its endorsement of the drug Avastin for breast cancer, a panel of cancer experts said yesterday, after follow-up studies failed to show benefits for patients.
A Food and Drug Administration panel of experts voted 12-1 in favor of removing the Roche drug's approval for use against breast cancer alongside chemotherapy. The FDA is not required to follow the advice of its panel, though it often does.
The negative vote is the first major setback for a blockbuster drug that has racked up approvals for half a dozen forms of the disease. Avastin is also approved for colon, lung, kidney and brain cancer. The panel's ruling pertains only to Avastin's use in breast cancer.
In 2008, the FDA approved Avastin for breast cancer patients based on a trial showing it extended the amount of time until the disease worsened by more than five months. The decision was considered controversial by some cancer doctors because the drug had not been shown to extend patients' lives.
As a condition of approval, Roche was required to conduct follow-up studies to demonstrate the benefits of adding Avastin to conventional chemotherapy.
Two follow-up studies recently submitted by the Swiss drugmaker did not show the same degree of delay in cancer progression as did earlier studies. And patients taking Avastin did not show a significant improvement in life span, the gold standard of cancer treatment effectiveness.
Roche scientists argued yesterday that patients taking Avastin experienced improved quality of life as tumor growth and other symptoms are delayed. Panelists were not convinced.
Panelists said they worried the drug could do more harm than good because of serious side effects, including high blood pressure, fatigue and abnormal levels of white blood cells.